Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

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Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.

Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. [ Time Frame: Day 0 up to Day 14 post-vaccination ]

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

1200

Completion Date

August 2009

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria :

Aged 12 to 18 months on the day of inclusion.

In good general health, without significant medical history.

Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.

Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.

Planned participation in another clinical trial during the present trial period.

Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.

Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.

Administration of any anti-viral within 2 months preceding V01.

History of central nervous system disorder or disease, including seizures.

Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

Planned receipt of any vaccine in the 4 weeks following any trial vaccination.

Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.

Receipt of any JE vaccine or hepatitis A vaccine.

Previous vaccination against flavivirus disease.

History of flavivirus infection (confirmed either clinically, serologically or microbiologically)